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DETOUR I: 18-month results encouraging for percutaneous bypass system
LAS VEGAS — A fully percutaneous bypass system using the femoral vein as a conduit benefited patients with long superficial femoral artery lesions at 18 months, according to data presented at VIVA 18.
As Cardiology Today’s Intervention previously reported, 30-day, 6-month and 12-month results of the DETOUR I trial of the PQ Detour procedure (PQ Bypass), a percutaneous technique in which revascularization is performed via modular stent graft bypass using the femoral vein as a conduit, showed the procedure was associated with high rates of patency, procedural success and improvement in Rutherford class.
Ehrin J. Armstrong, MD, MSc, FSCAI, director of the VA Eastern Colorado Health Care System and associate professor of medicine at University of Colorado School of Medicine, presented 18-month results here.
“The reality is, the current devices that are used for endovascular treatment were designed to treat short and relatively simple lesions,” Armstrong said during a press conference. “Endovascular approaches are usually considered the first option for shorter or less complex lesions. However, in the real world, a number of patients have long, complex lesions in the SFA and popliteal arteries, and ... the performance points that have been met are only in the range of 60% patency at 12 months. This includes complex lesions typically excluded from clinical trials, including long-segment chronic total occlusion, considerable calcification and in-stent restenosis. As a result, endovascular approaches have been consistently less durable than open bypass in these patients. With that in mind, the PQ Detour procedure was developed to approach this unmet need.”
The researchers enrolled 77 patients (mean age, 64 years; 83% men) with 81 SFA lesions at least 10 cm in length (mean, 37.1 cm; 96% with CTO; 67.5% with severe calcification) in the prospective, single-arm study.
At 18 months, primary patency was 67.6%, primary-assisted patency was 78.9% and secondary patency was 94.1%, Armstrong said during a presentation.
Safety outcomes were encouraging at 18 months, he said, noting that the rate of freedom from death was 98.5%, the rate of freedom from clinically driven target lesion revascularization was 74.6%, the rate of freedom from acute limb ischemia was 98.6% and the rate of freedom from major amputation was 98.6%.
More than 80% of patients were Rutherford class 0 at 18 months, and mean ankle-brachial index improved from 0.64 at baseline to 0.97 at 18 months, Armstrong said.
Enrollment is underway for the DETOUR II study, which is planned for 292 patients in the United States and Europe with femoropopliteal lesions of at least 15 cm, he said.
“The DETOUR I trial showed excellent long-term safety in patients with advanced disease and extremely long, complex lesions, with venous health maintained at 18 months,” Armstrong said during the presentation. “The promising durability at 18 months compares favorably with existing endovascular and open surgical durability.” – by Erik Swain
Reference:
Armstrong EJ, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.
Disclosure: The study was funded by PQ Bypass. Armstrong reports he has consulted for Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc., Intact Vascular, Medtronic and Philips, and he received research funding from Boston Scientific, Cardiovascular Systems Inc., Janssen, Medtronic, Mercator MedSystems, Merck, the NIH and Philips.
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It is impressive that we continue to see results with this system that are as good as a surgical bypass in lesions averaging 37 cm. It is also encouraging that the venous clinical scores remained good after treatment.
Typical drug-coated balloon and drug-eluting stent studies have patients with lesions 10 cm to 15 cm, but in the real world, we are treating patients with lesions 25 cm or more, and we are using a lot of technology at a lot of expense to do that. At 1 year, about 50% of current endovascular procedures fail in these patients. Hopefully, the DETOUR II trial will lead to U.S. approval of this system.
Department of Vascular Surgery
Sydell and Arnold Miller Heart & Vascular Institute
Cleveland Clinic
Chief Medical Officer
Excelerate Strategic Health Sourcing